RapidPulse Secures the US FDA’s Approval to Initiate IDE Study of Cyclic Aspiration System in Patients with Acute Ischemic Stroke
Shots:
- RapidPulse received the US FDA’s approval to initiate IDE study for its cyclic aspiration system. Data from the pivotal study will support a 510(k) clearance application
- The pivotal study will assess safety & efficacy of the RapidPulse Aspiration System in patients (n=170) having acute ischemic stroke (AIS) treatment within 8hrs. of symptom onset, suggesting large vessel occlusion (LVO), with recruitment across the US & EU planned in 2025
- A prior study showed 21-point improved first-pass clot removal rate. In a recent trial of 19 LVO patients in Paraguay and Turkey, the system achieved a 68% first-pass effect of TICI 2c or better, with 100% of them achieving TICI 2b or higher within three passes
Ref: RapidPulse | Image: RapidPulse
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
